Protopic Ointment in Adult Atopic Eczema of the Face

Launched by ASTELLAS PHARMA INC · Jun 3, 2008

Keywords

ClinConnect Summary

Treatments were to be applied twice daily over all lesions on the face (except for the eyelids) until clearance, for a maximum of 3 weeks and then, in case of uncleared residual lesions, once daily for up to 3 further weeks. In the event of a flare-up the treatment was to be resumed twice a day until the end of the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Moderate to severe AD (Rajka \& Langeland score) with lesions to the head and neck defined as 'red face' or 'facial eczema': erythema affecting at least 10% of the surface of the 'face' (head, neck, chest, nape of neck), due to long-term AD
• • At least two flare-ups of 'facial' eczema during the 12 months prior to inclusion and, in the investigator's opinion, conventional treatment had proved ineffective or poorly tolerated
• • Female patients of childbearing age: effective means of contraception throughout the period of the study and for four weeks following the end of the study
• • Informed consent
• • Therapeutic washout for atopic dermatitis treatments
• Exclusion Criteria:
• • Genetic epidermal barrier defect, such as Netherton's syndrome, or suffering from erythroderma
• • Seborrheic dermatitis or contact dermatitis affecting the 'face', or any other facial erythema of non-atopic origin
• • Clinical infection due to the VZV virus (varicella, zona), HSV1-2 viruses (herpes), verruca vulgaris or molluscum contagiosum
• • Superinfected eczema
• • Known hypersensitivity to macrolides or to any other excipient in tacrolimus 0.1% ointment
• • Known hypersensitivity to one of the agents contained in the fluticasone 0.005% ointment preparation
• • Ulcerated lesions, of whatever type
• • Moderate to severe acne or rosacea
• • Patients who participated at the same time in another clinical study or who had participated in another clinical study within 28 days prior to inclusion in the study
• • Any type of substance abuse (including that of drugs and alcohol) or any mental disorder/psychological state which, in the investigator's opinion, might interfere with the patient's follow-up
• • Serologically-proven HIV positivity